LOS ANGELES, Calif., Oct. 2, 2019 – Puma Biotechnology, Inc. (NASDAQ: PBYI) announced that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement for NERLYNX® (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 or higher diarrhea. Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesomide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone. READ MORE
Top-line analysis showed a highly statistically significant and clinically meaningful improvement in overall survival for CC-486
Celgene plans regulatory submissions beginning in 1H 2020
SUMMIT, N.J.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ: CELG) today announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001. The study evaluated the efficacy and safety of investigational therapy CC-486 as maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) who achieved first complete response (CR) or complete response with incomplete blood count recovery (CRi) with induction chemotherapy (with or without consolidation). The study demonstrated that maintenance treatment with CC-486 resulted in a highly statistically significant and clinically meaningful improvement in overall survival compared to placebo. The key secondary endpoint of relapse-free survival (RFS) also showed a statistically significant improvement. Read the full press release HERE.
The FDA recently approved Inrebic® (Fedretinib) for Myelofibrosis, the first new treatment in decades. Available as a once-daily oral dose, this is a new option for patients. Learn more: https://ir.celgene.com/press-releases/press-release-details/2019/US-FDA-Approves-INREBIC-Fedratinib-as-First-New-Treatment-in-Nearly-a-Decade-for-Patients-With-Myelofibrosis/default.aspx